Drug Master Files for: FELBAMATE

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FELBAMATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20438	I	II	4/12/2007	APICORE US LLC	FELBAMATE
21247	A	II	1/14/2008	PROCOS SPA	FELBAMATE
22201	I	II	11/20/2008	HETERO DRUGS LTD	FELBAMATE
>DMF No.	>Status	>Type	>Submission Date	>Holder	>Subject

Drug Master File Glossary

STATUS OF DMFS

A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
I = Inactive
N = Not an assigned number
P = DMF Pending Filing Review

TYPES OF DMFs

Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III Packaging Material
Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V FDA Accepted Reference Information

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